Chronic Dosing, Cross-Over Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma

Inclusion Criteria:

- ≥ 18 - 65 years of age

- Diagnosis of mild to moderate persistent asthma, diagnosed at least 6 months prior to
screening

- Currently receiving treatment with a low to medium dose of an inhaled corticosteroid
(ICS) OR a combination of controller medications for at least 4 weeks preceding
screening

- Pre-albuterol FEV1 of > 60% and < 85% of predicted normal value

- Reversibility: Increase in FEV1 of ≥ 12% and ≥ 200 mL over the pre-albuterol FEV1
within 30 - 60 minutes after the inhalation of 4 puffs of Ventolin hydrofluoroalkane
(HFA)

- Asthma Symptom Criteria: Have required albuterol use on at least two of the last
seven days and have an Asthma Control Questionnaire (ACQ) total score ≥ 1.5 prior to
Randomization

Exclusion Criteria:

- Life-Threatening Asthma: A subject must not have life-threatening asthma defined as a
history of significant asthma episode(s) requiring intubation associated with
hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal
episode(s) within the 12 months prior to screening

- Worsening of Asthma: A subject must not have experienced a worsening of asthma which
involved an emergency department visit, hospitalization or use of oral/parenteral
corticosteroids within 6 weeks of screening

- Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only
intermittent, seasonal or exercise-induced asthma are excluded from participation in
this study

- Concurrent Respiratory Disease

- Pregnant women or nursing mothers

- A current diagnosis of Chronic Obstructive Pulmonary Disease (COPD

- Current smokers or subjects with a > 10 pack year history of cigarettes, cigars, or
pipe smoking

- Respiratory tract infection within 6 weeks prior to Visit 1

- Subjects with documented myocardial infarction within a year from screening visit

- Clinically significant abnormal ECG

- Abnormal liver function tests defined as aspartate aminotransferase (AST), alanine
aminotransferace (ALT), alkaline phosphatase or total bilirubin ≥ 1.5 times upper
limit of normal on repeat testing

- Subjects who have cancer that has not been in complete remission for at least 5 years

- Drug Allergy: Subjects who have a history of hypersensitivity to any component of the
metered-dose inhaler (MDI)